FDAClass IIDecember 4, 2013

Synthes Matrix 5.5.mm Left and Right Coronal Bender recall

Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5…

Why was Synthes Matrix 5.5.mm Left and Right Coronal Bender recalled?

A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Parts 03.632.040 and 03.632.041 with various lot nos. Item Lot Number Number 03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995 Item Lot Number Number 03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005

Product
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5…
Recalling firm
Synthes USA HQ, Inc.
Quantity
209
Distribution
Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls